Project 2025 Tracker / What’s done, what’s next

14. Department of Health and Human Services · Minor

Let laboratory-developed tests be shared between laboratories

Not started

456 14. Department of Health and Human Services

“To encourage interlaboratory collaboration and discourage duplicative test creation (and associated regulatory and logistical burdens), the FDA should introduce mechanisms through which laboratory-developed tests can easily be shared with other laboratories without the current regulatory burdens.”

What has happened

  1. Not started

    FDA introduced no mechanism for sharing laboratory-developed tests between laboratories. The one in-window action on LDTs runs the other way round: after the Eastern District of Texas vacated FDA's May 2024 LDT rule on 2025-03-31, FDA published a final rule on 2025-09-19 reverting the definition of "in vitro diagnostic products" to its pre-2024 text. That restores the previous enforcement-discretion regime, in which a test sent to another laboratory falls outside LDT treatment altogether and is regulated as a distributed device - so it removes a burden without making sharing any easier.

Research log

What was searched, and what didn’t count as evidence

Research notes

  • Full-text Federal Register search for “laboratory developed test” since 2025-01-20 returns 0 documents; the vacatur rule is titled Medical Devices; Laboratory Developed Tests and was found by reading all 184 in-window FDA rules and proposed rules.
  • Boundary call: a reviewer who reads “without the current regulatory burdens” as the operative half of the ask would call the vacatur implementation partial.
  • Unified Agenda, checked 2026-09-01. Checked against the full HHS agenda on reginfo.gov (183 active RINs in the 2026 Unified Agenda, published 2026-08-14), not the abbreviated version the Federal Register prints. The nearest entry is recorded here; it does not name this ask’s object, so the Status is unchanged: an agenda entry, like a strategic plan, counts only when it names what the ask asks for.
    • The agenda carries no FDA laboratory-developed-test rulemaking at all. The nearest laboratory entry is CMS’s 0938-AV89 (CLIA Virtual Access, Gynecologic Cytology Proficiency Testing, Personnel Qualification Requirements, and Other Changes, CMS-3478, NPRM 09/2026), which modernizes CLIA oversight on three named points and says nothing about sharing tests between laboratories.
Action
create
Object
sharing mechanism for laboratory-developed tests
ID
1226